510(k) · Cleared
ClearedCeramic Femoral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Apr 12, 2024 as substantially equivalent to K173776 (Microport Orthopedics, Inc., 2018) and 2 other predicates after a 57-day review. Its family tree reaches back 11 generations to 1985. 3 of the 214 devices in its family, counting itself, have a Class I recall.
- Decided
- Apr 12, 2024
- Review
- 57 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K850055 (1985). 213 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet. 3 of the 214 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 7 generations between
- 3 generations backK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
- 2 generations backK151307 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
- 1 generation backK190704 Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd. · 2019
- This deviceK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK850055 Profile Femoral HipDepuy, Inc. · 1985
- 10 generations backK961378 Delta Hip ProsthesisZimmer, Inc. · 1996 · Recalled
- 9 generations backK992667 ZMR Hip System-Revision TaperZimmer, Inc. · 1999 · Recalled
- 8 generations backK994286 ZMR Hip System-Porous RevisionZimmer, Inc. · 2000 · Recalled
- 7 generations backK032726 Zimmer M/L Taper Hip Prosthesis, 7711 SeriesZimmer, Inc. · 2003 · Recalled
- 6 generations backK071723 Zimmer Porolock Mis StemZimmer GmbH · 2008 · Recalled
- 5 generations backK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- 4 generations backK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
- 3 generations backK131279 Iconacy I-Hip SystemIconacy Orthopedic Implants, LLC · 2013
- 2 generations backK151307 ICONACY (TM) I-Hip (TM)Iconacy Orthopedic Implants, LLC · 2016
- 1 generation backK190704 Signature Ceramic Femoral HeadSignature Orthopaedics Pty, Ltd. · 2019
- This deviceK240452 Ceramic Femoral HeadMicroport Orthopedics, Inc. · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K850055 | Profile Femoral Hip | Depuy, Inc. | 1985 | — |
| −10 | K961378 | Delta Hip Prosthesis | Zimmer, Inc. | 1996 | 4 |
| −9 | K992667 | ZMR Hip System-Revision Taper | Zimmer, Inc. | 1999 | 1 |
| −8 | K994286 | ZMR Hip System-Porous Revision | Zimmer, Inc. | 2000 | 11 |
| −7 | K032726 | Zimmer M/L Taper Hip Prosthesis, 7711 Series | Zimmer, Inc. | 2003 | 3 |
| −6 | K071723 | Zimmer Porolock Mis Stem | Zimmer GmbH | 2008 | 2 |
| −5 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| −4 | K121034 | Ioi Total Hip | Iconacy Orthopedic Implants, LLC | 2012 | — |
| −3 | K131279 | Iconacy I-Hip System | Iconacy Orthopedic Implants, LLC | 2013 | — |
| −2 | K151307 | ICONACY (TM) I-Hip (TM) | Iconacy Orthopedic Implants, LLC | 2016 | — |
| −1 | K190704 | Signature Ceramic Femoral Head | Signature Orthopaedics Pty, Ltd. | 2019 | — |
| 0 (this device) | K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 2 | 0 |
| 1983 | 1 | 0 |
| 1985 | 3 | 0 |
| 1986 | 3 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 25 | 0 |
| 1995 | 13 | 0 |
| 1996 | 15 | 0 |
| 1997 | 8 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 14 | 1 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 7 | 0 |
| 2004 | 5 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 1 |
| 2010 | 2 | 1 |
| 2011 | 7 | 0 |
| 2012 | 2 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K173776 | BIOLOX delta Option and Extra-long HeadsSummary page 5…Class II Subject Product Code and Orthopedics/87/ LZO Panel Code: Primary Predicate Device: BIOLOX delta Option and Extra-long Heads (K173776) Predicate Devices: Signature Ceramic Femoral Head (K190704) MicroPort Orthopedics Total… | 2018 |
| * | K190704 | Signature Ceramic Femoral HeadSummary page 5…dics/87/ LZO Panel Code: Primary Predicate Device: BIOLOX delta Option and Extra-long Heads (K173776) Predicate Devices: Signature Ceramic Femoral Head (K190704) MicroPort Orthopedics Total Hip Systems MR Labeling (K173898)… | 2019 |
| * | K173898 | MicroPort Orthopedics Total Hip Systems MR LabelingSummary page 5…Heads (K173776) Predicate Devices: Signature Ceramic Femoral Head (K190704) MicroPort Orthopedics Total Hip Systems MR Labeling (K173898) K240452 Page 1 of 3… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091423Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 11 Class I recall
- K003016Pro-Femur RWrightmedicaltechnologyinc · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
- K100866Profemur Hip System Modular NecksWrightmedicaltechnologyinc · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 7 companies; a new generation was cleared every 3.5 years on median.
- 46 of the 213 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K173776.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain
and/or improved hip function in skeletally mature patients with the following conditions:
1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis,
protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240452: Ceramic Femoral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240452
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026